Regulatory Manager
1 month ago
At Syneos Health, we are seeking a highly skilled Regulatory Manager to join our team. As a Regulatory Manager, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions/countries/projects.
Key Responsibilities:- Contribute to the planning and execution of regulatory submissions, including IND, PMA, NDA, MAA, and CTD.
- Manage day-to-day operations of project teams and projects, including line management responsibilities for staff members.
- Participate in and manage activities related to department staff operations, such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching, and mentoring.
- Approve courses of action on salary administration, hiring, corrective action, and terminations.
- Review and approve time records, expense reports, requests for leave, and overtime.
- Work with and advise staff on administrative policies and procedures, technical problems, priorities, and methods.
- Act as a representative of the regulatory department with other departments.
- Support business development, including generation of repeat business from existing clients and proposal development.
- Develop, review, and monitor project budgets; review client invoicing.
- Monitor personal utilization and utilization of direct reports.
- Act as a key point of contact for clients and regulatory authorities.
- Provide regulatory advice to Company associates.
- Conduct regulatory research on projects as needed.
- Provide strategic and operational advice to clients.
- Arrange, lead, and report on client and regulatory agency meetings.
- Write IND and product registration dossiers, clinical reports, and other regulatory documents.
- Manage project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post-approval maintenance activities.
- Act as a resource for technical knowledge.
- Participate in quality improvement efforts to increase overall operational efficiency.
- Contribute to the building of regulatory systems and infrastructure needed for GRAS.
- Develop a reputation for the Company as an industry leader in Regulatory by attending and speaking at industry events, authoring articles for trade journals, and participation in industry associations through memberships and on committees.
- Develop solutions to complex problems.
- Provide internal training in appropriate areas of expertise to other departments.
- BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device-related experience.
- Modest experience in regulatory.
- Demonstrated experience in contributing to the preparation of regulatory submissions, including IND, PMA, NDA, MAA, and CTD.
- Experience in niche submissions such as ODD, PIP/PMP an advantage.
- Comprehensive regulatory knowledge and understanding of pharmaceutical and/or medical device product development.
- Excellent interpersonal/communication skills, including excellent written and verbal communication skills.
- Excellent customer service skills, with the ability to work both as a team member and independently.
- Good quality management and budgeting skills.
- Good people management, project management, problem-solving, and decision-making skills.
- Advanced skills in Microsoft Office Applications.
- Ability to interact with staff from multiple departments and offices to establish project standards.
- Good initiative, adaptability, and proactivity.
- Strong analytical skills, good attention to detail.
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
- Fluent in speaking, writing, and reading English.
- A competitive annual base salary ranging from $71,820 to $139,600.
- A company car or car allowance.
- Health benefits, including medical, dental, and vision.
- A company match 401(k) plan.
- Eligibility to participate in the Employee Stock Purchase Plan.
- Eligibility to earn commissions/bonus based on company and individual performance.
- Flexible paid time off (PTO) and sick time.
At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.
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Regulatory Consulting Manager
2 months ago
Québec, Quebec, Canada Syneos Health Full timeAbout the RoleWe are seeking a highly skilled Regulatory Consulting Manager to join our team at Syneos Health. As a key member of our regulatory department, you will be responsible for managing regulatory submissions, leading project teams, and providing strategic advice to clients.Key ResponsibilitiesContribute to the planning and preparation of regulatory...
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Regulatory Consulting Manager
2 months ago
Québec, Quebec, Canada Syneos Health Full timeAbout the RoleWe are seeking a highly skilled Regulatory Consulting Manager to join our team at Syneos Health. As a key member of our regulatory department, you will be responsible for managing regulatory submissions, leading project teams, and providing strategic advice to clients.Key ResponsibilitiesContribute to the planning and preparation of regulatory...
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Québec, Quebec, Canada Syneos Health Full timeRegulatory Consulting ManagerAt Syneos Health, we are seeking a highly skilled Regulatory Consulting Manager to join our team. As a key member of our organization, you will be responsible for providing expert guidance on regulatory matters to ensure compliance with industry standards and regulations.Key Responsibilities:Develop and implement regulatory...
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